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Last Updated: December 13, 2025

Claims for Patent: 9,636,408


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Summary for Patent: 9,636,408
Title:Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride
Abstract:The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol or Amitriptyline HCl and mannitol.
Inventor(s):Marino Nebuloni, Patrizia Colombo
Assignee: Tonix Pharma Holdings Ltd , Redox SRL
Application Number:US14/214,433
Patent Claims: 1. A pharmaceutical composition comprising a eutectic composition of 25%±2% by weight of mannitol and 75%±2% by weight of Cyclobenzaprine HCl, wherein the euteutic composition melts at 143° C.±3° C.

2. The pharmaceutical composition of claim 1, further comprising a basifying agent.

3. The pharmaceutical composition of claim 2, wherein the basifying agent is K2HPO4 or Na2HPO4 or trisodium citrate.

4. A method of manufacturing the pharmaceutical composition of claim 1, wherein the method comprises mixing or milling a composition of 25%±2% by weight of mannitol and 75%±2% by weight of Cyclobenzaprine HCl.

5. The method of claim 4, wherein the method further comprises adding a basifying agent to the pharmaceutical composition.

6. The method of claim 5, wherein the basifying agent is K2HPO4 or Na2HPO4 or trisodium citrate.

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